Embodiments of the present invention encompass the use of a biofunctional, regenerative, reconstituted collagen biomatrix in conjunction with or without fibrin sealant, polyethylene glycol, or other materials, for treating defects in a visceral or parietal membrane, such as for preventing post-surgical tissue leaks and air leaks.
Prolonged postoperative tissue leaks and air leaks are a major cause of morbidity after pulmonary resection and other types of visceral or parietal membrane surgery and lead to prolonged drainage time which is associated with pain and immobilization. These complications put the patients at an increased risk for development of infections, bleeding, adhesions, pneumothorax and bronchopleural fistulae and consequently, a prolonged hospital stay, which increases healthcare costs. Surgical techniques to address this issue include the use of sutures or stapling devices with or without the concomitant use of surgical sealants, which have proven insufficient and have failed to eliminate tissue leaks or air leakage during pulmonary surgery.
A variety of complementary natural and synthetic materials have been tried with mixed results to overcome tissue leaks or air leaks during pulmonary resection. These materials include fibrin sealants and synthetic glues. In some cases, sealants have been used to enforce sutures or staple lines. However, they have had limited success and cannot replace an exact and precise surgical technique. Moreover, internal scarring, fibrosis, and adhesions after visceral or parietal membrane surgery are well known and undesired side effects of such surgery.
Consequently, a strong need exists for improved systems and techniques for directed and controlled tissue regeneration to treat or prevent post-surgical or post-traumatic tissue leaks, fluid leaks (e.g. blood, serous fluids, bile), or air leaks in lung tissue, and to promote tissue healing and regeneration process following surgical and traumatic injuries. There is also a need for matrices which do not absorb blood, which support the remodelling, regeneration, and the wound healing process, which direct the growth and the in-growth of cells. Further, there is a need for techniques that involve the replacement and regeneration of severed visceralis, such as pleura that covers the lung.
Embodiments of the present invention provide solutions for such needs. Aspects of the present invention encompass the use of a biofunctional collagen biomatrix, optionally with a fibrin sealant, for surgically treating visceral or parietal membranes and tissue defects after resection and for treating pulmonary tissue defects or defects of a visceral membrane, such as the pleura visceralis after lung resection surgery. The effectiveness of such techniques can be demonstrated by the results of an animal trial using a collagen biomatrix for the repair and regeneration of visceral defects. This collagen biomatrix provides a matrix with a special layer structure and includes pure naturally cross-linked collagen of equine origin. The biomatrix can act as a substitute for the severed visceralis or visceral membrane, and later, during the healing process as a regenerative biomatrix for the ingrowth of cells and formation of for example a visceral neo-pleura. The biomatrix may also act as an effective seal against fluid leaks, which is particularly advantageous as lung or organ function is greatly improved in the absence of fluid leaks in the visceral membrane. Relatedly, embodiments encompass the use of a collagen biomatrix for preventing post-surgical fluid leaks in pulmonary resection or other lung surgery or for treating defects of a visceral membrane such as a pleural membrane.